GLIPIZIDE tablet, film coated, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

Saatavilla:

Bryant Ranch Prepack

INN (Kansainvälinen yleisnimi):

GLIPIZIDE

Koostumus:

GLIPIZIDE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Glipizide extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Glipizide is contraindicated in patients with: - Known hypersensitivity to glipizide or any of the product’s ingredients. - Hypersensitivity to sulfonamide derivatives. Risk Summary Available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Clinical Considerations ). Poorly

Tuoteyhteenveto:

Product: 71335-0388 NDC: 71335-0388-1 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0388-2 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0388-3 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0388-4 100 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE Product: 71335-0851 NDC: 71335-0851-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0851-2 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0851-3 100 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0851-4 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-0851-5 180 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GLIPIZIDE- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIPIZIDE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GLIPIZIDE EXTENDED-RELEASE
TABLETS.
GLIPIZIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Glipizide extended-release tablets are a sulfonylurea indicated as an
adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Not for treatment of type 1 diabetes or diabetic
ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
Recommended starting dose is 5 mg once daily. Dose adjustment can be
made based on the patient’s glycemic control.
Maximum recommended dose is 20 mg once daily (2.1).
Administer with breakfast or the first meal of the day (2.1).
For combination therapy with other blood-glucose-lowering agents,
initiate the agent at the lowest recommended dose,
and observe patients for hypoglycemia (2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (3).
CONTRAINDICATIONS
Known hypersensitivity to glipizide or any of the product’s
ingredients (4)
Hypersensitivity to sulfonamide derivatives (4)
WARNINGS AND PRECAUTIONS
Hypoglycemia: May be severe. Ensure proper patient selection, dosing,
and instructions, particularly in at-risk
populations (e.g., elderly, renally impaired) and when used with other
anti-diabetic medications (5.1).
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase
(G6PD) deficient. Consider a non-sulfonylurea
alternative (5.2).
Potential Increased Risk of Cardiovascular Mortality with
Sulfonylureas: Inform patient of risks, benefits and treatment
alternatives (5.3).
Macrovascular Outcomes: No clinical studies have established
conclusive evidence of macrovascular risk reduction
with glipizide extended-release tablets or any other anti-diabetic
drug (5.4).
ADVERSE REACTIONS
Most common adverse react